@article{b26727a13301424badbc53c543514e4e,
title = "Design of the randomized, Phase III, QUAZAR AML Maintenance trial of CC-486 (oral azacitidine) maintenance therapy in acute myeloid leukemia",
abstract = "Older patients with acute myeloid leukemia (AML) have worse rates of complete remission and shorter overall survival than younger patients. The epigenetic modifier CC-486 is an oral formulation of azacitidine with promising clinical activity in patients with AML in Phase I studies. The Phase III, randomized, double-blind, placebo-controlled QUAZAR AML Maintenance trial (CC-486-AML-001) examines CC-486 maintenance therapy (300 mg/day for 14 days of 28-day treatment cycles) for patients aged ≥55 years with AML in first complete remission. The primary end point is overall survival. Secondary end points include relapse-free survival, safety, health-related quality of life and healthcare resource utilization. This trial will investigate whether CC-486 maintenance can prolong remission and improve survival for older patients with AML.",
keywords = "Acute myeloid leukemia, CC-486, De novo, Elderly, Maintenance therapy, Oral azacitidine, Phase III, Secondary",
author = "Roboz, {Gail J.} and Pau Montesinos and Dominik Selleslag and Andrew Wei and Jang, {Jun Ho} and Jose Falantes and Voso, {Maria T.} and Hamid Sayar and Kimmo Porkka and Paula Marlton and Ant{\'o}nio Almeida and Sanjay Mohan and Farhad Ravandi and Guillermo Garcia-Manero and Barry Skikne and Hagop Kantarjian",
note = "Funding Information: The CC-486-AML-001 trial is sponsored by Celgene Corporation. GJ Roboz{\textquoteright} institution received a grant from Celgene Corporation. PM Fernandes{\textquoteright} institution received a grant from Celgene Corporation. A Wei received a grant from Celgene Corporation. MT Voso received support for travel to the meeting for the study or other purposes from Celgene Corporation. F Ravandi-Kashani{\textquoteright}s institution received a grant from Celgene Corporation. B Skikne is employed by Celgene Corporation in which he has an equity interest. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Funding Information: The CC-486-AML-001 trial is sponsored by Celgene Corporation. GJ Roboz? institution received a grant from Celgene Corporation. PM Fernandes? institution received a grant from Celgene Corporation. A Wei received a grant from Celgene Corporation. MT Voso received support for travel to the meeting for the study or other purposes from Celgene Corporation. F Ravandi-Kashani?s institution received a grant from Celgene Corporation. B Skikne is employed by Celgene Corporation in which he has an equity interest. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Publisher Copyright: {\textcopyright} Gail J Roboz.",
year = "2016",
month = feb,
doi = "10.2217/fon.15.326",
language = "English",
volume = "12",
pages = "293--302",
journal = "Future Oncology",
issn = "1479-6694",
publisher = "Taylor and Francis Ltd.",
number = "3",
}
